Spoken Animation for Labour Epidural
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Participant views Epidural animation before reading gold standard written information, Participant receives current gold standard written information alone.
- Who it may be relevant to
- Registry conditions: Labour Pain. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of Spoken Animation as a Tool for Imparting Information About Epidural Labour Analgesia
Overview
The purpose of this study is to evaluate a new animated information film as a tool for introducing the concept of epidural as a method of labour pain relief to expectant women. The main question that the study is designed to answer is: Compared to written information alone, does the addition on a short animated introductory film reduce decisional conflict for expectant women regarding the use of epidural pain relief. Secondary outcomes tested will be change in anxiety and satisfaction scores after receiving the information. Study participants will include women expecting their first baby, presenting to hospital for induction of labour. They will be asked to fill out a questionnaire regarding thoughts and feelings around epidural, before and after receiving information about the procedure. Participants will be randomised to receive either traditional written information alone or with the addition of the animated film. A smaller number of participants will also be asked to participate in a short interview about the animated film.
Detailed description
This study is a prospective, randomised controlled trial with a pre-post design, as well as a qualitative analysis of user acceptability.
The planned sample size is 60 in control group, 60 in intervention group (120 in total). The study will only involve primiparous women presenting to the antenatal ward for induction of labour.
Participation in the study will take place on the antenatal unit, before transfer to labour ward. Participants will be asked to complete a pre-intervention survey regarding decisional conflict score for labour analgesia choices and including Likert scales for anxiety and understanding related to epidural.
They will then be given information about epidural for labour analgesia - the control group will receive written information alone; the intervention group will watch a short animation introducing the concept of epidural, followed by the same written information.
This will be followed by a post-intervention survey. A smaller group will be selected (dependent on availability of interviewer) for a short interview to allow qualitative analysis of the acceptability and effectiveness of the animation.
Interventions
- Other Participant views Epidural animation before reading gold standard written information
Addition of introductory animation to written OAA epidural information card about labour epidural - Other Participant receives current gold standard written information alone
Gold standard OAA (Obstetric Anaesthetists' Association) epidural information card
Primary outcome measures
- Change in Decisional Conflict Score [Time frame: Day 1]
Secondary outcome measures (2)
- Change in the following DCS subscore categories. [Time frame: Day 1]
- Self-reported Likert scale outcomes [Time frame: Day 1]
Eligibility criteria
Inclusion criteria
- Primiparous birthing people presenting for induction of labour.
Exclusion criteria
- Patient refusal
- Unable to speak English or any of the seven language translations provided
- Epidural contraindicated
- Previous Epidural for any reason
- Any significant health concerns
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
United Kingdom · 1 center
- West Middlesex Hospital, Chelsea & Westminster NHS Trust — London
Identifiers
NCT: NCT07202221 · 351150-SALE · 351150